510(k) · Cleared
ClearedDenali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd · DTK Filter, Intravascular, Cardiovascular
Cleared on Feb 29, 2024 as substantially equivalent to K160866 (C.R. Bard, Inc., 2016) after a 29-day review. Its family tree reaches back 11 generations to 2002.
- Decided
- Feb 29, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K022236 (2002). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
- 7 generations between
- 3 generations backK130366 Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery…C.R. Bard, Inc. · 2013 · Recalled
- 2 generations backK143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2014
- 1 generation backK160866 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2016
- This deviceK240257 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian…Bd · 2024
Show all 11 generations
- Root · 11 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
- 10 generations backK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
- 9 generations backK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
- 8 generations backK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
- 7 generations backK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
- 6 generations backK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008
- 5 generations backK093659 Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc. · 2010
- 4 generations backK101431 Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010
- 3 generations backK130366 Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery…C.R. Bard, Inc. · 2013 · Recalled
- 2 generations backK143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2014
- 1 generation backK160866 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2016
- This deviceK240257 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian…Bd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K022236 | Recovery Filter System, Model RF-048F | C.R. Bard, Inc. | 2002 | — |
| −10 | K050558 | Modification to: Recovery Filter System, Model RF-210F | C.R. Bard, Inc. | 2005 | — |
| −9 | K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J | Bard Peripheral Vascular, Inc. | 2005 | 2 |
| −8 | K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F… | C.R. Bard, Inc. | 2008 | — |
| −7 | K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)… | C.R. Bard, Inc. | 2008 | — |
| −6 | K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2008 | — |
| −5 | K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter… | C.R. Bard, Inc. | 2010 | — |
| −4 | K101431 | Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2010 | — |
| −3 | K130366 | Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit | C.R. Bard, Inc. | 2013 | 3 |
| −2 | K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System -… | C.R. Bard, Inc. | 2014 | — |
| −1 | K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System -… | C.R. Bard, Inc. | 2016 | — |
| 0 (this device) | K240257 | Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit | Bd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTK device
- #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian…Summary page 4…Class II Classification Panel: Cardiovascular Devices Product Code: DTK Predicate Devices: (K160866; Clearance April 29, 2016) Summary of Change: No changes have been made to the subject Denali™ Filter or Delivery System. The p… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DTK
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTK
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTK
432in 2025
MAUDE reports naming product code DTK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 87 | 1 | 364 |
| 2008 | 6 | 87 | 0 | 345 |
| 2009 | 3 | 380 | 0 | 456 |
| 2010 | 3 | 50 | 0 | 369 |
| 2011 | 2 | — | 0 | 439 |
| 2012 | 5 | 156 | 0 | 351 |
| 2013 | 3 | 91 | 1 | 473 |
| 2014 | 2 | — | 0 | 451 |
| 2015 | 2 | — | 1 | 859 |
| 2016 | 3 | 84 | 2 | 2,574 |
| 2017 | 5 | 88 | 0 | 4,364 |
| 2018 | 2 | — | 0 | 3,938 |
| 2019 | 0 | — | 6 | 6,467 |
| 2020 | 0 | — | 0 | 5,405 |
| 2021 | 2 | — | 0 | 5,357 |
| 2022 | 0 | — | 2 | 2,191 |
| 2023 | 0 | — | 0 | 583 |
| 2024 | 5 | 29 | 0 | 406 |
| 2025 | 0 | — | 1 | 432 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava
in the following situations:
-Pulmonary thromboembolism when anticoagulants are contraindicated
-Failure of anticoagulant therapy for thromboembolic disease
-Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are
reduced
-Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The Denali™ Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure
for Filter Removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240257: Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240257
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026